For certain pharmaceutical products (e.g., birth control pills), the government has required that in addition to the mandatory disclosure information provided to the pharmacist and/or physician, there must also be a disclosure circular provided for the patient. The two circulars are quite different in terms of information. This requirement has posed a significant problem for the pharmaceutical industry in that pharmaceutical suppliers are required to insure that every lot of product is shipped with both types of disclosure circulars and that at least the required member be present. For products that are packed in a shipping case, the supplier must make certain that there is at least one patient package circular for every individual product container and at least one pharmacist/physician circular in the shipping carton.
Historically, pharmaceutical companies have had extra personnel on the packaging lines to place all of these different pieces of literature, often by hand, into shipping cases. This is a labor-intensive operation, and errors are often made. A critical error arises where the leaflets provided do not correspond to the pharmaceutical being shipped.
In a prior attempt to address this problem, applicant developed a machine designed to take two or more standard leaflets and glue them together in a stack, one leaflet on top of the other. FIG. 8 shows an example of an assemblage of leaflets according to this design. Patient leaflets 92, for example, are releasably adhered to the surface of one another and then to a physician leaflet 90 by adhesive 94. In the case of a pharmaceutical product requiring one pharmacist/physician leaflet and multiple patient leaflets, the pharmaceutical product may be supplied with a multiple leaflet assembly as shown in FIG. 8. This design provides several important benefits. The design provides for convenient packaging of the leaflets, exact quantities of each type of leaflet, and the potential for automatic application to a package.
While the above-disclosed design has some very important benefits, new Federal regulations due to take effect in the near future create a major drawback for that design. These regulations mandate that all pharmaceutical cut literature assemblies, including leaflets in the form of outserts and inserts, must be verified electronically prior to application to a pharmaceutical product. The most cost-effective means of electronic verification is a bar code. The problem with the above-disclosed design is that if there are more than two leaflets separately formed and joined together in a stack, it is not feasible to verify each component electronically by a bar code (e.g., for a three leaflet label, one could electronically verify the two leaflets on the ends of the assemblage, but could not verify the leaflet sandwiched between the other two). Thus, for accurate and convenient electronic verification, the design disclosed above is only appropriate for literature assemblies having two leaflets.
Thus, there exists the need for a multiple leaflet assembly which provides for accurate and convenient verification of a plurality of extended text leaflets forming a single literature assembly.
It is often necessary to provide information for the patient in more than one language. However, it is necessary that the disclosures in each language be verified. One way of achieving this is to print the disclosures in each language on a single sheet which is folded into a multi-panel leaflet. The patient must locate the appropriate language, disregarding the other language(s). This arrangement presents an unduly cumbersome leaflet because very often the leaflet will have a number of panels which serve no further purpose, being in a language unreadable by the patient, but which nonetheless must be refolded.
In some instances, the patient must be provided with a series of different but related disclosures such as daily instructions for administering a pharmaceutical product. Again, it is necessary that these related disclosures be verified. This may be accomplished by printing each of the series of instructions on a single sheet which is thereafter folded into a multi-panel leaflet. This approach has a significant drawback in that the patient must repeatedly unfold and refold the leaflet, including panels bearing instructions which have already been referenced and are no longer needed. The continued presence of such instructions increases the risk that the patient may be confused and follow the older, inappropriate instructions.
In some instances, a pharmaceutical manufacturer or distributor may desire to collect consumer feedback or consumer information, e.g., demographic information. One method for collecting such information is to provide the patient leaflet with a detachable return card. The patient fills out the form on one side of the card and deposits the card for return to an address pre-printed on the other side of the card. A rebate or the like may be offered as an incentive to return the card. One problem with this method is that many consumers are reluctant to provide confidential and even non-confidential information on the card because it may be exposed during mailing. Also, the return envelope must comply with certain minimum dimensions required by the United States Postal Service.
It is known to provide a printed sheet, for example, a billing statement, which may be converted, for example, by a billed customer, into a return envelope. Typically, the return envelope is sealed by wetting a strip of dry adhesive provided on the sheet and mating selected panels of the sheet. Some users find the wetting step objectionable. Further, there is a risk that the user will not properly activate the adhesive or mate the panels, so that the envelope is not suitably formed and sealed for the rigors of postal handling.